Non-small Cell Lung Cancer
Conditions
Keywords
Apatinib, Non-small Cell Lung Cancer, VEGFR TKIs
Brief summary
Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.
Interventions
DRUGapatinib
750 mg，po，QD； 28 days every cycle
DRUGplacebo
po，QD； 28 days every cycle
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 18 to 70 years of age 2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions 3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy 4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1 5. Patients had to have recovered from any toxic effects of therapy 6. Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation 7. Adequate hematologic and biochemical values were required
Exclusion criteria
1. Presence of small-cell lung cancer alone or with NSCLC 2. Pregnant or breast-feeding women 3. Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \> 140 mmHg，diastolic pressure \> 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency 4. Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction) 5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy 6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks 7. Bone fracture or wounds that was not cured for a long time 8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents 9. Mental diseases and psychotropic substances abuse 10. Previous treatment with an experimental agent within 4 weeks 11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS 12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 24 months | Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | 24 months | ORR was the percentage of patients who got partial or complete response |
| Overall Survival(OS) | 24 months | OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up |
| Toxicity | 24 months | Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment. |
Countries
China
Outcome results
None listed